ES2 SPINAL SYSTEM 48280145Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04546540710413), received between Apr 13, 2016 and Nov 12, 2025 — classified as 4 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Fracture” (30 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Fracture; Fracture

  A CUSTOMER REPORTED THAT THE TIP OF AN ES2 CANNULATED MODULAR TAP FRACTURED INTRA-OPERATIVELY AND THAT THE FRACTURED COMPONENT REMAINS IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536758 ↗
• MalfunctionSep 16, 2025Fracture; Fracture

  A CUSTOMER REPORTED THAT THE DISTAL TIP OF AN ES2 CANNULATED MODULAR TAP FRACTURED INTRA-OPERATIVELY AND THAT THE FRACTURED COMPONENT REMAINS IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066129 ↗
• InjuryDec 17, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF AN ES2 CANNULATED MODULAR TAP FRACTURED OFF INSIDE THE PATIENT'S RIGHT L3 VERTEBRAL BODY INTRA-OPERATIVELY. SUBSEQUENTLY, FIXATION WAS SKIPPED AT THAT LEVEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 5 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026533 ↗
• MalfunctionMar 30, 2021Fracture; Fracture

  IT WAS REPORTED THAT A "CRACK" WAS OBSERVED IN THE TIP OF AN ES2 CANNULATED MODULAR TAP DURING POST-OPERATIVE CLEANING. SURGERY HAD SUCCESSFULLY BEEN COMPLETED WITH THE DEVICE AND NO DELAY. NO FRAGMENTS OF THE DEVICE WERE LEFT IN THE PATIENT. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590494 ↗
• MalfunctionDec 8, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF AN ES2 CANNULATED MODULAR TAP BROKE OFF IN THE L5 PEDICLE INTRA-OPERATIVELY. THE BROKEN PIECE WAS LEFT IN DUE TO THE PATIENT'S HARD BONE. SURGERY WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10971265 ↗
• MalfunctionOct 22, 2020Fracture; Fracture

  IT WAS REPORTED THAT AN ES2 CANNULATED MODULAR TAP TIP WAS FOUND FRACTURED DURING INTRA-OP INSPECTION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10722244 ↗
• MalfunctionJun 18, 2019Fracture; Break; Fracture; Detachment of Device or Device Component

  PHYSICIAN REPORTED THE TIP OF AN ES2 CANNULATED MODULAR TAP BROKE OFF IN THE VERTEBRAL BODY DURING IMPLANT SURGERY. THE ENTRY POINT WAS EXPANDED AND THE BROKEN TIP WAS REMOVED AFTER A 30-MINUTE DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACK-UP DEVICE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 8708267 ↗
• InjuryDec 10, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT JAMSHIDI BROKE INTRA-OP AND 40MM OF IT STUCK IN THE PATIENT PEDICLE. THE PEDICLE HOLE WAS ENLARGED TO REMOVE STUCK JAMSHIDI. AS PER EMAIL COMMUNICATION, TAP WAS USED AND TIP OF IT BROKEN INTRA-OP. MAJORITY OF THE BROKEN FRAGMENTS WERE RETRIEVED. A SURGICAL DELAY OF 2 HOURS WAS REPORTED.

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 8149016 ↗
• InjuryDec 10, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT JAMSHIDI BROKE INTRA-OP AND 40MM OF IT STUCK IN THE PATIENT PEDICLE. THE PEDICLE HOLE WAS ENLARGED TO REMOVE STUCK JAMSHIDI. MAJORITY OF THE BROKEN FRAGMENTS WERE RETRIEVED. AS PER EMAIL COMMUNICATION, TAP WAS USED AND BONE STUCK. A SURGICAL DELAY OF 2 HOURS WAS REPORTED.

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 8148881 ↗
• MalfunctionJul 30, 2018Break; Fracture; Fracture

  IT IS REPORTED THAT THE THREADS OFF THE TAP BROKE INSIDE THE PATIENT L4 RIGHT PEDICLE. NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO SURGICAL DELAY IS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7732531 ↗
• MalfunctionApr 24, 2018Fracture; Break; Detachment Of Device Component; Fracture

  IT IS REPORTED THAT WHILE TAPING WITH 4.5 DIAMETER CANNULATED TAP, A 3-4MM PIECE OF THE TIP OF THE TAP BROKE OF AND WAS LODGED IN THE BONE OF THE PEDICLE. IT TOOK ABOUT 45 MINUTES FOR SURGEON TO RETRIEVE AND REMOVE BROKEN TIP. NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7455683 ↗
• MalfunctionMar 29, 2018Fracture; Fracture; Component Missing; Failure to Advance

  IT WAS REPORTED THAT DURING AN MIS T LIFT, THE TAP WOULD NOT ADVANCE. THE TAP WAS REMOVED AND THE TIP OF IT WAS MISSING. THE PIECES WERE IN THE BODY. HOUR AND HALF SURGICAL DELAY TO REMOVE PIECES, SOME PIECES REMAINED INSIDE THE BODY.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 7381683 ↗
• MalfunctionDec 27, 2017Break; Detachment Of Device Component; Fracture; Fracture

  IT WAS REPORTED THAT; DURING USE OF THE SPINAL SYSTEM, WHILE USING THE 4.5MM TAP OVER A NITINOL K-WIRE, THE TIP OF THE TAP BROKE OFF INTO THE VERTEBRAL BODY PATIENT. THE MISSING FRAGMENT WAS NOT RECOVERED AND LEFT INSIDE THE PATIENT

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7149240 ↗
• MalfunctionOct 30, 2017Break; Entrapment of Device; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; INSERTED THE TAP 4.5MM BEFORE IMPLANTING SCREW, AND REMOVED THE TAP. IT WAS COMFIEMED TO BROKE THE TIP OF TAP AFTER REMOVAL. THE BROKEN PART WAS REMAIN IN PATIENT. IT IS THOUGHT THAT IT IS CAUSED BY PATIENT'S OSSEOUS SCLEROSIS.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6989416 ↗
• MalfunctionSep 19, 2017Fracture; Break; Fracture

  IT WAS REPORTED THAT WHEN THE SURGEON USED THE 4.5 MM TAP TO THE RIGHT SIDE, ITS TIP BROKE. THE SURGEON REMOVED ALL THE FRAGMENTS AND INSERTED A SCREW.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6877394 ↗
• MalfunctionAug 21, 2017Fracture; Material Integrity Problem; Break; Detachment Of Device Component; Fracture; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT; SURGEON WAS USING THE TAP, AND THE THREADS OF THE TAP BROKE OFF IN THE PATIENT'S PEDICLE. THE SURGEON WASN'T ABLE TO REMOVE THE THREADS, SO HE THEN CONTINUED TO TAP WITH A 5.5MM TAP AND INSERTED THE SCREW.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6809336 ↗
• MalfunctionJul 17, 2017Fracture; Difficult to Insert

  IT WAS REPORTED THAT; TREATED FOR T12 FRACTURE, IT WAS PERFORMED TO FIX THE T11, T12, L1, L2. FOR L2 RIGHT PEDICLE, THE NEEDLE COULD NOT BE INSERTED BECAUSE THE BONE WERE HARD. SO HIT THE BONE BY HAMMER, HOWEVER IT COULD NOT INSERT IT FROM THE WAY. THEN ATTEMPTED TO INSERT USING THE TAP OF THE SMALLEST SIZE, BUT THE TAP WAS BROKEN. TIP OF BROKEN TAP WAS REMOVED OUT OF PATIENT BODY. FINNALLY, IT WAS COMPLETED THE PROCEDURE WITHOUT IMPLANTING THE SCREW FOR L2.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 6720062 ↗
• MalfunctionJul 14, 2017Fracture; Break; Fracture

  IT WAS REPORTED THAT; TAP BROKE DURING USE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6713943 ↗
• MalfunctionJun 19, 2017Fracture; Material Integrity Problem; Break; Fracture; Loose or Intermittent Connection; Material Integrity Problem

  IT WAS REPORTED THAT; TAP 4.5 DIAMETER DAMAGED AT TIP. JAMSHIDI PEDICLE (L5) IS PUNCTURES, IMMEDIATE SCREW POSITIONED 6.5MM DIAMETER OVER K-WIRE. DID NOT WORK. TAP 5.5 DIAMETER AS PREPARATION, DID NOT SUCCEED. TAP 4.5 DIAMETER. UPON DEPARTURE, TAP IN BONE, CHECK IF TAP IN BONE LEFT THROUGH C-ARCH LATERAL PROJECTION. ON RX, IT WAS SEEN THAT THE THREAD OF THE 4.5-DIAMETER CAPPED TAP HAD COME LOOSE.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6652078 ↗
• MalfunctionMay 2, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; DURING SURGERY THE TIP OF THE TAP BROKE WHEN IT WAS USED TO L4 RIGHT SIDE. THE TIP IS REMAINED TO THE PATIENT. THE BROKEN PART REMAINED IN L4.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6537200 ↗
• MalfunctionApr 17, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; IT WAS NOTED AFTER 4.5 CANNULATED TAP WAS USED THAT THE TIP WAS BROKEN. A NEW TAP WAS OPENED THEN USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6498749 ↗
• MalfunctionMar 14, 2017Break; Fracture; Kinked; Fracture

  IT WAS REPORTED THAT THE SALES REP REPRESENTATIVE REPORTED THAT THE TIP OF THE TAP BROKE INSIDE THE PATIENT DURING THE PROCEDURE. THE SALES REP FURTHER REPORTED THAT THE K WIRE WAS INSERTED. THERE WAS A KINK IN THE K WIRE WHICH HAPPENED DURING THE INSERTION PROCESS. THE TAP WAS PLACED DOWN THE K WIRE AND THE SURGEON BEGAN TAPPING. WHEN HE REMOVED THE TAP THERE WAS DEBRIS INSIDE THE PATIENTS BONE, WHICH HE ASSUMED TO BE THE TIP OF THE TAP. THE DEBRIS APPEARED TO BE IN ONE PIECE. THE SURGEON DID NOT ATTEMPT TO GET THE TIP OF THE TAP OUT OF THE PATIENT BECAUSE THE PROCEDURE WAS UNDERTAKEN USING A MINIMALLY INVASIVE TECHNIQUE AND REMOVAL OF THE TIP WOULD HAVE MADE THE PROCEDURE MORE INVASIVE. THE SURGEON REPORTED THAT HE WAS NOT UNDULY CONCERNED ABOUT THE UNINTENDED METAL IN THE PATIENT. THE SALES REPRESENTATIVE WAS IN THE CASE.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6402161 ↗
• MalfunctionMar 1, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT; TIP BROKE DURING SURGERY. UPDATE 2/282017: TIP REMAINS IN THE VERTEBRAL BODY. NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6370585 ↗
• MalfunctionMar 1, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT; TIP BROKE DURING SURGERY. UPDATE (B)(6) 2017: TIP REMAINS IN THE VERTEBRAL BODY. NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6370581 ↗
• MalfunctionNov 15, 2016Fracture; Material Integrity Problem; Break; Fracture; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT; SURGEON WAS TAPPING WITH 4.5 TAP AND TIP BROKE OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6104703 ↗